Data / Medical devices / Solid State X-Ray Imager (Flat Panel/Digital Imager)
Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB): 98 FDA-registered makers in 17 countries
98 establishments in 17 countries are registered with the FDA to make Solid State X-Ray Imager (Flat Panel/Digital Imager) (product code MQB, Class 2, 21 CFR 892.1680). 61 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 424 510(k) clearances under this code, the latest on July 31, 2026, and lists 113 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MQB
- Device class
- 2
- Regulation
- 892.1680
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 25 |
| South Korea | 20 |
| China | 14 |
| Japan | 12 |
| India | 5 |
| Italy | 5 |
| Germany | 4 |
| Israel | 3 |
| Canada | 2 |
| Belgium | 1 |
| Taiwan | 1 |
| Spain | 1 |
| Sweden | 1 |
| Brazil | 1 |
| Mexico | 1 |
| Australia | 1 |
| Netherlands | 1 |
Makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Rayence Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 30 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 19 | October 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | Kawasaki Kanagawa, Japan | Specification developer | 19 | October 17, 2022 | 0 | 1 | 0 | api.fda.gov |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 19 | October 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HINO-SHI Tokyo, Japan | Complaint file establishment, Specification developer | 19 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta Technoproducts Co., Ltd. | SAYAMA-SHI Saitama, Japan | Manufacturer | 18 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 18 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Agfa N.V. | Mortsel Antwerpen, Belgium | Complaint file establishment, Manufacturer, Specification developer | 17 | November 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| iRay Group | Shanghai, China | Complaint file establishment, Manufacturer, Specification developer | 15 | February 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Careray Digital Medical Technology Co., Ltd. | SuZhou Jiangsu, China | Manufacturer | 13 | August 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 13 | March 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Agfa-Gevaert Healthcare GMBH | PEISSENBERG Bavaria, Germany | Manufacturer | 11 | November 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| Carestream Health, Inc | Rochester, NY, United States | Complaint file establishment, Manufacturer | 11 | October 9, 2025 | 0 | 1 | 0 | api.fda.gov |
| Vieworks Co., Ltd. | Anyang-si Gyeonggi, South Korea | Complaint file establishment, Exporter to the US, Specification developer | 11 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vieworks Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 11 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Compass Innovations, Inc | Santa Clara, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 10 | December 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Complaint file establishment, Manufacturer | 9 | April 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| LG Electronics Inc. | Gumi-si Gyeongbuk, South Korea | Exporter to the US, Manufacturer | 8 | July 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 7 | April 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems DMC GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 7 | September 30, 2020 | 0 | 3 | 0 | api.fda.gov |
| Innocare Optoelectronics Corp. | Tainan, Taiwan | Contract manufacturer, Manufacturer | 6 | July 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta Healthcare Americas, Inc | Garner, NC, United States | Manufacturer | 6 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Diagnostic X-ray Business Unit | Bengaluru Karnataka, India | Specification developer | 5 | September 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Diagnostic X-ray Business Unit | Pimpri Maharashtra, India | Specification developer | 5 | September 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| H&abyz | Yongin-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 4 | March 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Radlink, Inc. | El Segundo, CA, United States | Manufacturer, Repackager or relabeler | 4 | September 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. | Seoul, South Korea | Complaint file establishment, Specification developer | 4 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 4 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Varex Imaging Corporation | Salt Lake City, UT, United States | Manufacturer | 4 | December 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bontech Co., Ltd | Suwon-si Gyeonggi, South Korea | Exporter to the US, Manufacturer | 3 | April 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 3 | October 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 3 | October 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| PixxGen Corporation | Anyang-si Gyeonggi, South Korea | Manufacturer | 3 | June 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| iCRco Inc. | Goleta, CA, United States | Manufacturer, Repackager or relabeler | 3 | July 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Biokinemetrics Inc. | Carroll, IA, United States | Manufacturer | 2 | March 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Del Medical, Inc. | Bloomingdale, IL, United States | Manufacturer | 2 | July 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 2 | November 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Kub Technologies, Inc. | Stratford, CT, United States | Manufacturer | 2 | June 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Oehm Und Rehbein GMBH | ROSTOCK Mecklenburg-Western Pomerania, Germany | Manufacturer | 2 | August 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Pzmedical Technology Co., Ltd. | Putuo District Shanghai, China | Manufacturer | 2 | August 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Radisen Co Ltd | Anyang Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 2 | May 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| RadmediX, LLC | Dayton, OH, United States | Manufacturer, Repackager or relabeler | 2 | July 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| SG Healthcare Co Ltd | Moga-myeon, Icheon-si Gyeonggi, South Korea | Manufacturer, Repackager or relabeler | 2 | July 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| A.T.S. Applicazione Tecnologie Speciali s.r.l. | Torre de Roveri Bergamo, Italy | Manufacturer | 1 | July 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aspen Imaging Healthcare, Inc | Plano, TX, United States | Manufacturer | 1 | February 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Astel.inc | Yuseong-gu Daejeon, South Korea | Manufacturer | 1 | August 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Carestream Health, Inc., Global R&D Center | Shanghai, China | Specification developer | 1 | October 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dentium Co.,ltd(ict Branch) | Suwon Gyeonggi, South Korea | Manufacturer | 1 | June 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Digiray Corp | Daejeon, South Korea | Manufacturer | 1 | January 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| First Source Inc. | Rochester, NY, United States | Specification developer | 1 | March 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office | MINAMIASHIGARA-SHI Kanagawa, Japan | Manufacturer | 1 | August 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Imaging System (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | August 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 1 | November 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer, Specification developer | 1 | November 17, 2006 | 0 | 30 | 0 | api.fda.gov |
| JPI Healthcare Co., Ltd | Seoul, South Korea | Complaint file establishment, Exporter to the US, Manufacturer | 1 | February 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ka Imaging Inc. | Waterloo Ontario, Canada | Manufacturer | 1 | September 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medicatech Usa | Anaheim, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nical SPA | MILAN (MI) Lombardy, Italy | Manufacturer | 1 | January 6, 2006 | 0 | 0 | 0 | api.fda.gov |
| Prognosys Medical Systems Private Limited | Bengaluru Karnataka, India | Manufacturer | 1 | November 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sedecal S.A. | ALGETE Madrid(Province), Spain | Manufacturer | 1 | March 21, 2014 | 0 | 1 | 0 | api.fda.gov |
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Complaint file establishment, Manufacturer | 1 | June 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Arcoma AB | VAXJO Kronoberg, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accogent Pausch | Eatontown, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alliage S/A Industrias Medico Odontologica | Ribeirao Preto Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CMT Medical Technologies, Ltd. | YOKNEAM ILLIT Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | York, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drgem Corporation | Gwangmyeong-si Gyeongbuk, South Korea | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRGEM Corporation (Gimcheon Factory) | Gimcheon-si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dagesh F.K. Ltd. | Yad Binyamin Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Medical Merate S.P.A. | Seriate, Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Halifax Biomedical Inc. | Mabou Nova Scotia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iray Imaging LLC | Solon, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iray Korea Limited | Seoul, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-X Ltd | Tonsley South Australia, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minxray, Inc. | Northbrook, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-X Imaging Ltd | PETAH TIKVA Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omega Medical Imaging, LLC | Sanford, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthoscan, Inc. | Scottsdale, AZ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiology Information Systems, Inc. | Dulles, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | Shantou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | SHANTOU Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Industries, LLC | Niles, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Source-Ray, Inc. | Ronkonkoma, NY, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Villa Sistemi Medicali S.P.A. | BUCCINASCO Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xline SRL | ASSAGO Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zentech Manufacturing, Inc | Baltimore, MD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iRay Imaging Technology (Haining) Limited | Haining Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iRay Imaging Technology Taicang Limited | Taicang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.